The use of intraluminal prosthetic devices has been demonstrated to present an alternative to conventional vascular surgery. Intraluminal prosthetic devices are commonly used in the repair of aneurysms, as liners for vessels, or to provide mechanical support to prevent the collapse of stenosed or occluded vessels.
Intraluminal endovascular prosthetics involves the percutaneous insertion of a generally tubular prosthetic device, such as a stent, into a vessel or other tubular structure within the vascular system. The stent is typically delivered to a specific location inside the vascular system in a compressed state by a catheter. Once delivered to the desired location, the stent is deployed by expanding the stent into the vessel wall. The expanded stent typically has a diameter that is several times larger than the diameter of the stent in its compressed state. The expansion of the stent may be performed by several methods known in the art, such as by a mechanical expansion device (balloon catheter expansion stent) or by self-expansion.
The positioning of the stent within the vessel is a critical factor that affects the performance of the stent and the success of the medical procedure. Since the region in the vessel lumen at which the stent is to be deployed is usually very difficult for a physician to access, it is essential that the stent's deployed diameter and length be known before the physician can accurately position the correctly sized device.
Careful sizing of the correct stent for the desired region of the vessel lumen may be a difficult challenge for many physicians. Although the dimensions of the body vessel at the region may be known, uncertainty about the stent's exact deployed diameter and length may lead to less than optimal performance. One cause for uncertainty in the stent's deployed diameter and length is a condition known as foreshortening.
Foreshortening can be better understood by defining the condition within the context of change in the stent length before and after deployment. For the purpose of this definition, “crimped length” describes the starting point of the stent—that is the length of the unexpanded stent mounted on a delivery catheter prior to deployment. The term “deployed length” is defined at the clinical end point of change—that is the length of the stent deployed within the lumen. Foreshortening is equivalent to the distance between these two points, i.e. the difference between the contained (“crimped”) and deployed length.
Foreshortening occurs to varying degrees with all stents. This is especially true for endovascular stents greater than 4 millimeters in diameter. The amount of stent foreshortening is determined predominately by how the particular stent design accommodates expansion. For example, self-expanding stents are commonly deployed by operation of a retractable sheath. As the sheath is retracted the distal end of the stent is released first. Foreshortening can occur within this distal segment until the stent anchors on the lumen wall. As the sheath retraction continues, the proximal segment will foreshorten as it is deployed.
Balloon-expandable stents also foreshorten during expansion. Stents deployed by standard catheter balloons invariably see the balloon inflate at the weakest section first. Typically, the weakest section of the balloon will be at the exposed distal and/or proximal ends, i.e. the sections of the balloon not supported directly by the catheter or the stent. Accordingly, as the balloon is expanded the proximal end and/or distal end(s) of the balloon will inflate first. The inflated end(s) of the stent will experience the pressure of the balloon pressing outward in a radial direction to expand the stent, and also inwardly in an axial compressive direction. This axial compressive force causes the weaker connecting links or “flex links” of the stent to compress, causing the stent to foreshorten.
What is needed is an intraluminal medical device that will accommodate the device expansion into the wall of the lumen, while minimizing device foreshortening.